Label: SURFACE SHEER TOUCH SPF 30 SUNSCREEN- octocrylene, avobenzone, homosalate lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 72344-106-01, 72344-106-02 - Packager: Surface Products Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 3, 2022
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INGREDIENTS AND APPEARANCE
SURFACE SHEER TOUCH SPF 30 SUNSCREEN
octocrylene, avobenzone, homosalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72344-106 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 6 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 mL Inactive Ingredients Ingredient Name Strength SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CARBOMER 934 (UNII: Z135WT9208) TRIETHANOLAMINE 2-CYCLOHEXYL-4,6-DINITROPHENOLATE (UNII: N2TK31JIAH) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) .ALPHA.-(.ALPHA.-AMINOPROPYL)BENZYL ALCOHOL HYDROCHLORIDE, ERYTHRO-(+/-)- (UNII: 3IIJ9C722I) POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) WATER (UNII: 059QF0KO0R) DIMETHICONE 500 (UNII: 5L1VVC3K8O) STEARIC ACID D7 (UNII: T3B081197X) SORBITOL (UNII: 506T60A25R) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72344-106-01 177 mL in 1 TUBE; Type 0: Not a Combination Product 03/03/2022 2 NDC:72344-106-02 88.7 mL in 1 TUBE; Type 0: Not a Combination Product 03/03/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/03/2022 Labeler - Surface Products Corp (010777036) Establishment Name Address ID/FEI Business Operations Inspec Solutions LLC. 081030372 manufacture(72344-106)
